India Wants 1,000 New Clinical Trial Sites. Patients Are Still Being Left In The Dark.

Three years ago, while waiting for a follow up consultation in a hospital in Delhi, a woman who was not part of the hospital staff approached Bhalla—she asked her to provide a blood sample and sign a consent sheet to take part in a gastrointestinal clinical trial. But she did not explain why.

Bhalla asked for the information sheet or details of the study, but that only annoyed the woman, who she assumed was a trial coordinator, she said. Since no one came forward to explain the study, she refused to participate.

Experts say Bhalla’s experience isn’t a one-off occurrence. This is even as India’s regulatory framework covering clinical trials was significantly strengthened after the Supreme Court’s intervention in 2013, and subsequent amendments were made to the Drugs & Cosmetics Rules.

New rules include provisions for compensation to trial participants, and recording consent on video, especially among vulnerable populations. These, and mandatory registration of ethics committees with the central licensing authority (CDSCO) have improved safeguards for participants, said Poonam Bagai, founder and chairman, CanKids…KidsCan, which also hosts the Pediatric Cancer Research Institute (pCRI), an initiative focused on patient-centred paediatric oncology research.

However, “the video recording of the consent process of vulnerable trial participants isn’t happening,” said Amulya Nidhi of the Swasthya Adhikar Manch, a not-for-profit working in the clinical trials space.

Bagai said the consent process still often lacks true comprehensibility, limiting informed decision-making. “Consent forms may exist, but the key question is whether patients and families genuinely understand what participation means,” she said, noting that low health literacy remains a significant barrier in India. “Consent or assent for paediatric populations is another important area to address.”

Studies such as this conducted among rural adolescents and this among hypertensive adults show that anywhere between 60% and 75% of the population is insufficiently informed.

“Many patients who participate in clinical trials in India aren’t aware that they could suffer an adverse drug reaction, contrary to getting better, nor are they aware of their rights in such an eventuality,” said Nidhi.

Further, “the Supreme Court has recommended the establishment of an apex committee to approve new clinical trials, and for those approvals to be based on a risk-benefit-analysis, on the innovation quotient of the new therapy and its usefulness versus existing therapies, and on the unmet medical needs of the country. Still, no such apex committee meeting has happened; and trials are being independently approved,” said Nidhi.

As India moves to expand clinical trials, with the 2026-27 budget allocating Rs 10,000 crore over five years to strengthen biopharma and establish 1,000 accredited new clinical trial sites, there is a pressing need to improve patient awareness and ensure their rights are upheld.

To successfully scale clinical trials, a mindset shift from ‘guinea pig’ to ‘aware patient’ and the promotion of active patient participation is key, said Pooja Sharma, CEO, APAR Health, an organisation working to promote patient-centric research.

Awareness must to eliminate vulnerability among potential participants

Low health literacy can make families more vulnerable, especially at emotionally difficult moments such as a serious diagnosis like cancer, Bagai said.

“At the same time, limited understanding may also prevent families from considering participation in legitimate research that could offer meaningful treatment opportunities,” she added.

National level policies and programmes are seen as the best way to promote health literacy but so far these have failed in delivering health information to underserved populations, according to an analysis of health inclusivity by the Economist.

“The need of the hour is widespread public awareness initiatives in urban as well as rural India, something like the Reserve Bank of India (RBI) does to create awareness in the financial sector,” said Alishan Naqvee, one of India’s leading healthcare lawyers.

“Such campaigns need to be carefully crafted, as we are a large population with a huge disease burden,” said Naqvee. “A campaign shall not discourage participation in clinical trials, just as the RBI’s campaigns do not discourage people from opening bank accounts.”

In particular, awareness campaigns must target the most vulnerable people. For instance, “many trials are conducted in tribal areas, where there is a lack of health facilities and services, among less educated people,” said Vinod Shende, a health rights activist from Pune, Maharashtra. “Investigators organise free treatment camps, and illiterate, poor people get taken in.”

Alongside potential participant awareness, Sharma said there is a need for more aware researchers, who must understand “patient centricity”, and more aware clinicians who must be “aware of research as a care option”.

Subject recruitment still a grey area

India’s regulatory framework still doesn’t lay down clear guidelines for the recruitment process. “In India,” Nidhi said, “patients are usually enrolled from hospital out-patient clinics, unlike in the West where the trial is advertised and details such as the ethics committee members and other bits of information are clearly stated.”

Greater transparency in recruitment extends to informed consent. “Patients must be informed of the possibility of an adverse drug reaction, and that they have the right to pull out of the trial and be compensated for a loss,” said Nidhi, stressing that “this still doesn’t happen as it should.”

In the case of early phase clinical trials, unexpected adverse effects or even benefits are unknown at the time of designing the trial, and hence not mentioned in the consent documents. But patients must be made to understand this.

In August 2025, a participant of a trial for cardiac failure drugs who was promised Rs 20,000 for partaking was allegedly threatened by the company conducting the trial in Hyderabad, when he complained of severe chest pain and enormous worry because a fellow participant had succumbed to similar complaints a few days previously. Contrary to being treated, the participant was given Rs 500 and referred to a government hospital.

“It’s important to observe how consent functions on the ground,” said Preetisha Choudhury, a scholar researching the regulation of informed consent in clinical trials at the Department of Law, North-Eastern Hill University in Meghalaya’s Shillong. “In many instances, patients may have signed a consent form but not truly understood the purpose of the trial, the risks involved, and their right to withdraw.”

“Socio-economic vulnerability and therapeutic misconceptions can affect [a] patient’s understanding of a trial,” she added.

Therapeutic misconceptions refer to patients anticipating better care through the trial than existing treatment, and being attracted to participate in trials because of the promise of free treatment. Intense patient counselling is crucial to minimise ‘therapeutic misconceptions’, concluded this Tata Memorial Centre study of cancer trials.

Finance administration missing from regulatory framework

A public interest litigation filed by the Swasthya Adhikar Manch in the Supreme Court in April 2025, alleging investigator impropriety at the Sheth VS General Hospital, Ahmedabad, a municipal-run hospital, prompted a probe by the Drugs Controller General of India (DCGI).

A preliminary report by a five-member team of the Ahmedabad Municipal Corporation (AMC) confirmed financial irregularities in 58 clinical trials being conducted in the hospital, involving more than 500 patients.

About 15 doctors including the hospital’s medical superintendent were found to have diverted Rs 1.87 crore to their personal accounts over the previous four years.

Eight contractual doctors were dismissed and one faculty member was suspended.

A member of the AMC’s investigating team, on the condition of anonymity, told IndiaSpend that he blamed gaps in the regulatory framework for this scandal.

“Our existing regulatory framework adequately addresses the clinical aspects but it omits the financial and administrative aspects of a trial,” he said. “We need a policy covering the disbursements of funds, essentially, which stipulates how the trial budget should be disbursed—how much the principal investigator will get, how much the co-investigator will get, how much the hospital will get, and so on.”

“We studied the agreements of 62 clinical trials being conducted at the Sheth VS General Hospital, and insofar as the patients-related part was concerned, everything was in order,” he continued. “But the disbursements under different expenditure heads varied for each, which isn’t appropriate. We need a standard, fair policy for clinical trial budget disbursements across India.”

“Disbursements to the hospital supporting the trial, to cover the overheads, must also be clearly mentioned in the policy; it shouldn’t be left to the discretion of the institution,” said the investigating team member, adding that “Sheth VS General Hospital’s share hadn’t been disbursed.”

A senior officer of the AMC reportedly told the Times of India in 2025 that the investigating DCGI team didn’t recall “conducting routine inspections at the VS Hospital clinical trial site over the past four years”.

“It appears that the DCGI is short of regulators to monitor trials across the country,” said Nidhi.

As 1,000 new accredited trial sites come online, Bagai pointed out that the government will need to strengthen monitoring. “Oversight should be risk-based and enabling, ensuring ethical standards without discouraging responsible research.”

“Expansion is not inherently problematic,” said Choudhury. “But without careful monitoring, public trust may suffer.”

IndiaSpend has reached out to the health ministry and the AMC for comment on financial irregularities and trial monitoring lapses. The AMC directed us to individual officers but has not provided a response on record. The health ministry did not respond to queries at the time of publishing. We will update this story when we receive responses.

Ethics committee lapses bear adversely upon trials

Every institution conducting trials must have an ethics committee in place to review consent documents, monitor the conduct of clinical trials and even halt their progress if irregularities are identified in their conduct, and safeguard participant’s rights.

Ideally, the institution should appoint a third-party autonomous ethics committee composed of institutional representatives, community representatives, local health not-for-profits and public health experts.

Bagai added that patient and caregiver representation within ethics review and oversight processes is important, though structured participation remains limited in practice.

It’s also important that the ethics committee doesn’t report to the institution, said Nidhi. “Only then can it provide the right checks and balances.”

In the Sheth VS General Hospital, the trials were being overseen by an external private ethics committee.

Now that the budget has tabulated plans to increase infrastructure and accredited sites to strengthen research capacity, the focus must also be on growing ethical safeguards at the same pace, said Choudhury.

Accreditation for ethics committees on the lines of accreditation for hospitals (National Accreditation Board for Hospitals, or NABH domestically and the Joint Commission International, or JCI, globally), may be an appropriate safeguard.

“Our ethics committee (IEC-3, ACTREC, Tata Memorial Centre) is registered with the DCGI as well as the Department of Health Research and is one of the very few ethics committees in India to be accredited by international agencies such as Strategic Initiative for Developing Capacity for Ethical Review (SIDCER),” said Sachin Punatar, member secretary, IEC-3 (ethics committee), ACTREC, Tata Memorial Centre, Navi Mumbai.

With the planned expansion of clinical trial sites, Nidhi proposed that the government appoint a representative for each, possibly as a member of the ethics committee.

Punatar said that in order to maintain the highest standards, new trial sites and newly registered ethics committees should be closely monitored until they acquire adequate experience.

Recommendations for a healthier clinical trial scenario

Clinical trials are considered as one of the best ways to advance science and improve patient outcomes. “India needs more clinical trials, particularly in oncology where survival outcomes remain uneven across geographies and innovation is critical,” Bagai said. Incidentally, of thousands of registered clinical trials running in India, oncology is among the fastest growing segments.

In oncology, there has been a tremendous improvement in patient outcomes through decades of research, said Punatar. “Trials to test new medicinal products in patients who have exhausted all standard therapies may offer a ray of hope for patients who may not have any further treatment options.”

However, nothing has been said so far about the kind of trials to be run at the 1,000 new trial sites, nor the kinds of sites to be promoted, said Nidhi.

“Clarity would help patients’ rights groups mobilise adequate support,” he said. “Trials should take place in public institutions.”

To strengthen accountability, Shende underscored the need for a speedy, easily accessible grievance redressal mechanism, helpline and online portal for patients participating in the trial, and for action to be taken on these complaints within a specific timeframe.

“Faster and more accessible grievance mechanisms would strengthen accountability,” agreed Choudhury, while also underscoring the need for “a more contextual consent model that adapts communication to participants’ realities”.

Additionally, “if India is investing Rs 10,000 crore in research infrastructure, some of that investment should also support patient education and patient-advocacy capacity building,” said Bagai.

Global frameworks such as the US FDA’s Patient-Focused Drug Development initiative and the European Medicines Agency’s patient engagement framework show that patient involvement improves trial design, retention and ethical robustness. So, “government engagement with initiatives such as PACER, which build the capacity of patient advocates to participate in research design, patient-led research, and public education, will be vital to creating a more ethical and patient-centred clinical research ecosystem,” Bagai said.

“For India to become a global clinical research hub, the focus must extend beyond laboratories and trial sites to building informed patients and informed communities.”

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